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| Sponsored by: |
Eli Lilly and Company |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00042562 |
Purpose
The purposes of this study are to determine:
The safety of duloxetine and any side effects that might be associated with it.
Whether duloxetine can help patients with major depression.
The safety associated with switching from a medication you may be taking for depression to taking duloxetine.
It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: duloxetine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Los Angeles, California, United States | |
| Carlsbad, California, United States | |
| Stanford, California, United States | |
| United States, Connecticut | |
| Cromwell, Connecticut, United States | |
| United States, Florida | |
| Coral Springs, Florida, United States | |
| Gainesville, Florida, United States | |
| Miami, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| United States, Maine | |
| Bangor, Maine, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| United States, New York | |
| Rochester, New York, United States | |
| New York, New York, United States | |
| United States, Ohio | |
| Cincinnati, Ohio, United States | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Houston, Texas, United States | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Falls Church, Virginia, United States | |
| Richmond, Virginia, United States | |
| Charlottesville, Virginia, United States | |
| United States, Washington | |
| Seattle, Washington, United States | |
| United States, Wisconsin | |
| West Allis, Wisconsin, United States | |
More Information
| Study ID Numbers: | 6476, F1J-US-HMBZ |
| Study First Received: | July 31, 2002 |
| Last Updated: | July 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00042562 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Depressed blues sadness |
feelings of guilt hopelessness lack of energy |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Fatigue Depression Adrenergic Agents Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Serotonin Uptake Inhibitors |
Duloxetine Serotonin Behavioral Symptoms Dopamine Mental Disorders Mood Disorders Dopamine Agents Antidepressive Agents |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Depressive Disorder |
Serotonin Uptake Inhibitors Duloxetine Pharmacologic Actions Behavioral Symptoms Serotonin Agents Mental Disorders Therapeutic Uses Mood Disorders Dopamine Agents Central Nervous System Agents Antidepressive Agents |